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Biotech Stock Roundup: Management Changes at Biogen, Alexion, GILD Files HIV Drug
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Biogen (BIIB - Free Report) and Alexion were both in the headlines this week with the companies announcing management changes -- while Biogen’s shares were down on the news, Alexion’s shares soared. Meanwhile, Gilead (GILD - Free Report) continues to work on strengthening its HIV franchise with the company now seeking FDA approval for a once-daily single tablet regimen.
Recap of the Week’s Most Important Stories
Biogen Loses, Alexion Gains on Management Shakeup: Biogen’s long-standing CFO, Paul Clancy, will be leaving the company at the end of the second quarter to join as CFO of Alexion. Biogen has seen quite a few top position exits over the last few quarters with this being the latest. Biogen’s shares were down 3.1% while Alexion’s investors reacted positively to the news with shares gaining 9.3% (Read more: Biogen Loses Top Executive Again, CFO Clancy to Join Alexion).
Year-to-date (YTD), Biogen has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company losing 10.7% while the industry is up 2.6%.
Celgene Lupus Drug Looks Promising: Celgene’s investigational, oral immunomodulatory compound fared well in a mid-stage study in lupus with a trend toward greater improvement being observed. With treatment options for lupus remaining limited, there is significant demand for new treatments.
Meanwhile, Celgene entered into a five-year strategic collaboration with Dragonfly Therapeutics, which uses its novel TriNKET technology to harness the body's innate immune system to bring breakthrough cancer treatments to patients.
Under the collaboration, Celgene will get exclusive options to in-license up to four of Dragonfly's pipeline candidates focused on high-value targets in hematological malignancies including acute myeloid leukemia and multiple myeloma. Celgene will shell out $33 million upfront and make milestone as well as royalty payments.
AbbVie (ABBV - Free Report) has also signed up with Principia Biopharma, a private, clinical-stage company, for the development of oral immunoproteasome inhibitors. The companies will work on developing first-in-class oral therapies that bring the power of proteasome inhibition safely into the field of immunology. Both Celgene and AbbVie are Zacks Rank #3 (Hold) stocks -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Acceleron Drops Dalantercept Development: Clinical-stage company, Acceleron , has decided to shelve the development of dalantercept after it failed in a mid-stage study in advanced renal cell carcinoma (RCC). The company, which is working on developing treatments for serious and rare diseases, has now decided to focus on lead pipeline candidate, luspatercept, which is in several mid- and late-stage studies. Luspatercept is being developed for different types of blood cancer in partnership with Celgene (Read more: Acceleron Kidney Cancer Candidate Fails in Phase II).
CRL for Neulasta Biosimilar: Amgen (AMGN - Free Report) got a bit of a breather with the FDA issuing a complete response letter (CRL) to Coherus for its biosimilar version of Amgen’s blockbuster drug Neulasta. While the FDA has not asked for a clinical study, the agency has requested a reanalysis of a subset of subject samples with a revised immunogenicity assay and has also asked for certain additional manufacturing related process information. Neulasta is a key product in Amgen’s portfolio with 2016 sales coming in at $4.6 billion including $3.9 billion in the U.S. Coherus intends to work with the FDA to determine the path forward. On its first quarter call, Amgen had said that it could start facing biosimilar completion for Neulasta as early as the fourth quarter of the year.
Gilead Seeks FDA Nod for HIV Regimen: Gilead submitted a regulatory application in the U.S. seeking FDA approval for a once-daily single tablet regimen which has the potential to advance triple-therapy treatment (BIC/FTC/TAF) for a wide range of HIV patients. Gilead enjoys a strong presence in the HIV market and is working on launching new products. With the hepatitis C virus (HCV) franchise under pressure, Gilead is looking towards its HIV segment to drive results (Read more: Gilead Submits NDA for HIV Combination Therapy Regimen). The company expects to file for EU approval of the regimen in the third quarter.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 1% over the last five trading sessions. Among major biotech stocks, Alexion gained 17.8% while Regeneron lost 1.1%. Over the last six months, Vertex was up 59.2% while Gilead was down 14.2%.
What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
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Biotech Stock Roundup: Management Changes at Biogen, Alexion, GILD Files HIV Drug
Biogen (BIIB - Free Report) and Alexion were both in the headlines this week with the companies announcing management changes -- while Biogen’s shares were down on the news, Alexion’s shares soared. Meanwhile, Gilead (GILD - Free Report) continues to work on strengthening its HIV franchise with the company now seeking FDA approval for a once-daily single tablet regimen.
Recap of the Week’s Most Important Stories
Biogen Loses, Alexion Gains on Management Shakeup: Biogen’s long-standing CFO, Paul Clancy, will be leaving the company at the end of the second quarter to join as CFO of Alexion. Biogen has seen quite a few top position exits over the last few quarters with this being the latest. Biogen’s shares were down 3.1% while Alexion’s investors reacted positively to the news with shares gaining 9.3% (Read more: Biogen Loses Top Executive Again, CFO Clancy to Join Alexion).
Year-to-date (YTD), Biogen has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company losing 10.7% while the industry is up 2.6%.
Celgene Lupus Drug Looks Promising: Celgene’s investigational, oral immunomodulatory compound fared well in a mid-stage study in lupus with a trend toward greater improvement being observed. With treatment options for lupus remaining limited, there is significant demand for new treatments.
Meanwhile, Celgene entered into a five-year strategic collaboration with Dragonfly Therapeutics, which uses its novel TriNKET technology to harness the body's innate immune system to bring breakthrough cancer treatments to patients.
Under the collaboration, Celgene will get exclusive options to in-license up to four of Dragonfly's pipeline candidates focused on high-value targets in hematological malignancies including acute myeloid leukemia and multiple myeloma. Celgene will shell out $33 million upfront and make milestone as well as royalty payments.
AbbVie (ABBV - Free Report) has also signed up with Principia Biopharma, a private, clinical-stage company, for the development of oral immunoproteasome inhibitors. The companies will work on developing first-in-class oral therapies that bring the power of proteasome inhibition safely into the field of immunology. Both Celgene and AbbVie are Zacks Rank #3 (Hold) stocks -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Acceleron Drops Dalantercept Development: Clinical-stage company, Acceleron , has decided to shelve the development of dalantercept after it failed in a mid-stage study in advanced renal cell carcinoma (RCC). The company, which is working on developing treatments for serious and rare diseases, has now decided to focus on lead pipeline candidate, luspatercept, which is in several mid- and late-stage studies. Luspatercept is being developed for different types of blood cancer in partnership with Celgene (Read more: Acceleron Kidney Cancer Candidate Fails in Phase II).
CRL for Neulasta Biosimilar: Amgen (AMGN - Free Report) got a bit of a breather with the FDA issuing a complete response letter (CRL) to Coherus for its biosimilar version of Amgen’s blockbuster drug Neulasta. While the FDA has not asked for a clinical study, the agency has requested a reanalysis of a subset of subject samples with a revised immunogenicity assay and has also asked for certain additional manufacturing related process information. Neulasta is a key product in Amgen’s portfolio with 2016 sales coming in at $4.6 billion including $3.9 billion in the U.S. Coherus intends to work with the FDA to determine the path forward. On its first quarter call, Amgen had said that it could start facing biosimilar completion for Neulasta as early as the fourth quarter of the year.
Gilead Seeks FDA Nod for HIV Regimen: Gilead submitted a regulatory application in the U.S. seeking FDA approval for a once-daily single tablet regimen which has the potential to advance triple-therapy treatment (BIC/FTC/TAF) for a wide range of HIV patients. Gilead enjoys a strong presence in the HIV market and is working on launching new products. With the hepatitis C virus (HCV) franchise under pressure, Gilead is looking towards its HIV segment to drive results (Read more: Gilead Submits NDA for HIV Combination Therapy Regimen). The company expects to file for EU approval of the regimen in the third quarter.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 1% over the last five trading sessions. Among major biotech stocks, Alexion gained 17.8% while Regeneron lost 1.1%. Over the last six months, Vertex was up 59.2% while Gilead was down 14.2%.
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What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
3 Stocks to Ride a 588% Revenue Explosion
At Zacks, we're mostly focused on short-term profit cycles, but the hottest of all technology mega-trends is starting to take hold...
By last year, it was already generating $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for those who make the right trades early. See Zacks' Top 3 Stocks to Ride This Space >>